BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 15829772 · Received November 19, 2022

    Report

    Report Number
    9610595-2022-04287
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    October 18, 2022
    Report Date
    January 10, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER ARE IN PROGRESS. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE BENDING ANGLE IN THE UP DIRECTION EXCEEDED STANDARD VALUES DUE TO DEFORMATION OF THE BENDING TUBE, THE UPWARD/DOWNWARD KNOB COULD NOT BE LOCKED SECURELY DUE TO DAMAGE TO THE LEVER, THE ADHESIVE ON THE BENDING SECTION COVER HAD A CHIP, THE SCOPE CONNECTOR CASE UNIT WAS DEFORMED, THE AIR/WATER CYLINDER WAS DEFORMED, THE SUCTION CYLINDER WAS DEFORMED, THE FORCEPS CHANNEL PORT WAS DEFORMED, AND THE RIGHT/LEFT KNOB WAS DEFORMED. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REPORTED THE SCOPE WAS NOT USED IN BETWEEN POSITIVE TESTS. THE SCOPE WAS REPROCESSED CORRECTLY USING ONE OF THE THREE AUTOMATIC ENDOSCOPE REPROCESSORS (AER) AT THE SITE. THE SITE'S STEPS TO REPROCESS THE SCOPE INVOLVED LEAK TESTING, BRUSHING DOWN EACH CHANNEL, WIPE DOWN OF THE SCOPE WITH CLOTH, AND THEN REPROCESSING WITH THE AER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE CUSTOMER NOTED THE SCOPE HAD POSITIVE MICRO TESTS 4-5 TIMES. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607577 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown